Retrieval snare for extracting foreign objects from body cavities and method for manufacturing thereof

ABSTRACT

A retrieval snare for entrapping and retaining a foreign object located in a body and a method for manufacturing of the snare are provided. The snare comprises a structure having a proximal portion and a distal portion and includes a plurality of filaments. The filaments extend from an end of the proximal portion towards the distal portion and return to the end of the proximal portion to form a plurality of loops. The loops are not interconnected at the distal portion, but each side of each loop are connected to a side of an adjacent loop in the proximal portion at more than one point, thereby providing structural rigidity and dilatation ability to the snare.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/850,369, filed on Oct. 6, 2006, entitled “RETRIEVAL SNARE FOREXTRACTING FOREIGN OBJECTS FROM BODY CAVITIES AND METHOD FORMANUFACTURING THEREOF,” the entire contents of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to an extraction device capable ofcapturing and releasing objects from hollow bodies, and in particular,to a medical instrument for ensnaring and removing an object from abody.

2. Background of the Invention

Various instruments are known in the art for removing foreign objectsfrom the body. For example, such instruments are used for removal ofstones such as kidney stones, gallstones, and the like from varioussites along the urinary tract of a patient's body. Retrieval devices arealso widely used for removing foreign articles from the vascular systemof a patient. In such a case, examples of the foreign articles includevena cava filters and parts of medical devices, such as catheters,guidewires, cardiac leads, etc., which may break and become detachedduring medical procedures.

Some types of these instruments employ a retrieval collapsible wirebasket arranged within a flexible catheter formed as a tubular sheathadapted to penetrate body passages to reach the location where theobject is to be evacuated. Another known type of the retrieval device isa snare configured as a single distal loop which is positioned over afree end of the foreign body, and which is collapsed and tightenedaround the foreign body.

In an attempt to provide a snare with improved cross sectional vesselcoverage, multi loop snares have been developed. These snares includerelatively free loops which are not joined at any point between theshaft and the distal ends of the loops. One drawback of many multi-loopsnares is that the relative geometry of the free loops is difficult tomaintain due to the lack of dilatative strength. These snares are notresistive to forces countering snare opening. Because the relativeposition of the loops can change, both within a catheter and within abody tract, the loops can actually become displaced and/or entangled,thus preventing the snare to be opened during operation.

BRIEF SUMMARY OF THE INVENTION

There is a need to provide a convenient and safe retrieval snaresuitable for the reliable and efficient extraction of foreign objectsfrom body tracts. The present invention satisfies the aforementionedneed by providing a retrieval snare suitable for entrapping andretaining a foreign object located in a body for its extractiontherefrom. The snare comprises a structure having a petal shape andincluding a proximal portion and a distal portion. It should be notedthat in the description and claims that follow, the terms “proximal” and“distal” are used with reference to the operator of the snare.

The structure is constituted by a plurality of filaments. The filamentsextend from an end of the proximal portion towards the distal portionand return to the end to form a plurality of loops. The loops are notinterconnected in the distal portion. Each side of each loop is directlyconnected to a side of an adjacent loop in the proximal portion at morethan one point, thereby to provide structural rigidity and dilatationability to the snare.

According to an embodiment of the invention, the connection of the sidesof the loops along the proximal portion is achieved by twisting eachpair of the filaments forming the corresponding sides by one or moreturns. Preferably, but not mandatory, the twisting is such that thedistal connection points of the adjacent loops move from twisted partsof the loops toward the distal portion of the snare when the snare isretracted in a dilator sheath. Thus, when the twisting is formed by atleast two turns, an intermediate portion between the proximal portionand the distal portion of the snare is formed. The intermediate portionincludes convex cells formed between the distal points and the remainingtwisted parts by the corresponding pair of the filaments separated fromeach other. In turn, when the twisting is formed by only one turn, theconvex cells are formed between the end and the distal connectionpoints.

The filaments are bound together at the end of the proximal portion. Forexample, the filaments at the end of the proximal portion can be boundtogether by a ferrule. According to an embodiment of the invention, thefilaments which are bound together at the end of the proximal portionform a manipulation member.

According to one embodiment of the invention, the filaments are made ofnon-metallic material. Examples of the non-metallic material include,but are not limited to, Capron, Nylon, etc.

According to another embodiment of the invention, the filaments are madeof metallic material. The metallic material can have a thermo-mechanicalshape memory characteristic. Moreover, the metallic material can have asuperelastic characteristic. Examples of the metallic material include,but are not limited to, NiTi based alloy and stainless steel.

When desired, the metallic material includes a material which providesradiopacity. For example, the material which provides radiopacity is anoble metal. Likewise, the metallic material can be alloyed with one ormore of the following metals: palladium (Pd), tungsten (W), niobium(Nb), cobalt (Co), gold (Au), silver (Ag), Tantalum (Ta), and copper(Cu).

According to one embodiment of the invention, the filaments are made ofa core tube (cannular strand) containing an axially disposed radiopaquewire.

According to another embodiment of the invention, the filaments arecovered by a coating layer. Preferably, but not mandatory, the coatinglayer is made of a radiopaque material.

According to a further embodiment of the invention, the retrieval snarecan include at least one radiopaque marker attached to at least one loopin said distal portion. For example, the radiopaque marker is a ferruleplaced around the filament.

According to one embodiment of the invention, the filaments aresingle-core wires.

According to another embodiment of the invention, the filaments aremultiwire strands. For example, the multiwire strands can include acentral core wire and at least one another wire twisted about saidcentral core wire. This another wire can, for example, be made of amaterial having a level of radiopacity greater than the level ofradiopacity of the central core wire. For example, this another wire canbe made of or include one or more of the following metals: Pt, Au, Pd,W, Nb, Co, Ag, Ta, and Cu.

According to another aspect of the invention, there is provided aretrieval snare apparatus including the snare structure described aboveand a snare control assembly coupled to the snare structure. The snarecontrol assembly comprises a dilator sheath adapted to penetrate intothe body for reaching the object, a manipulator for manipulating thesnare for extraction of the object from the body, and a manipulationmember arranged within the dilator sheath for connecting the snare tothe manipulator. The manipulation member can, for example, be connectedto the manipulator through a ferrule placed around the manipulationmember and the manipulator. The snare control assembly is configured forretracting the snare within the sheath and protracting the snaretherefrom for its opening.

According to one embodiment of the invention, the manipulation memberincludes at least a part of the plurality of filaments extending fromthe proximal end towards the manipulator. For example, the manipulationmember can include a tube containing these filaments axially disposedwithin a lumen of the tube along at least a portion of the tube'slength.

According to one embodiment of the invention, the filaments extendedfrom the end of the proximal portion towards the manipulator are cut offat a predetermined distance from the end, thereby forming free ends ofsaid plurality of filaments. The manipulation member includes a rodelement connected to these free ends, for example, through a ferruleplaced and crimped around the rod element and around said free ends.When desired, the ferrule includes a notch configured for facilitationof connection of the rod element to the ferrule by one or moreconnecting techniques, such as soldering, welding and/or gluing.

Examples of the material from which the manipulation member is madeinclude, but are not limited to, NiTi based alloy, stainless steel andpolymer.

According to another aspect of the invention, there is provided a methodfor manufacturing a novel retrieval snare for entrapping and retaining aforeign object located in a body for its extraction therefrom. Accordingto one embodiment of the invention, the method includes selecting apredetermined number of filaments; and providing a weaving jig having aworking surface.

The working surface of the weaving jig has a central portion and aperipheral portion. The working surface has a predetermined convex shapedefining an opening angle of the snare, and a predetermined patternformed by radial channels configured on the surface. At least a part ofthe radial channels is formed in the form of a plurality of notchesextending from a center of the surface towards its periphery. Thenotches are not interconnected at the peripheral portion of the workingsurface, but each notch shares a common part with at least one notch ofan adjacent radial channel in the central portion of the workingsurface.

The method further includes placing the filaments into the radialchannels to form a plurality of filament loops with free parts of thefilaments arranged in the center of the working surface. Then, thefilament loops disposed at the peripheral portion of the working surfaceare fastened to the jig. For example, the fastening of the filamentloops to the jig at the peripheral portion of the working surface can becarried out by tying up the filaments by at least one string woundaround the jig.

Further, each side of each filament loop disposed in the common part ofthe radial channels is connected to a side of an adjacent filament loopat more than one point. For example, the connecting of these sides ofthe filament loops can be achieved by twisting each pair of thefilaments forming the corresponding sides.

Further, the method includes temporarily fastening the free parts of thefilaments arranged in the center of the working surface together.

Thereafter, the method includes annealing (thermal treatment) of theretrieval snare, thereby to store the snare shape and impart structuralrigidity and dilatation ability to the snare. According to an embodimentof the invention, the annealing of the snare includes heating at atemperature in the range of about 400° C.-600° C. over about 10 minutes.It should be understood that generally time of the thermal treatment maybe shorter or longer than 10 minutes, depending on the heatingtechnique, jig mass, etc.

For example, the heating can be carried out in a furnace. According toanother example, when the filaments are made of electrically conductivematerial, the heating can be carried out by passing an electric currentthrough the filaments. Depending on the current magnitude, the thermaltreatment can be in the range of several seconds to tens of secondslong.

Further, the retrieval snare is cooled; the parts of the filaments tiedin the center and at the peripheral portion of the working surface areunfastened; and the jig is removed.

The method also includes the step of binding the free parts of thefilaments together. For example, the free parts of the filaments can bebound together by a ferrule.

According to one embodiment of the invention, the structure of the snarecan be fabricated from a single length of wire.

According to another embodiment of the invention, the structure of thesnare can be fabricated from several wires.

The method of fabrication of the snare can further include forming amanipulation member. The forming of the manipulation member can includetwisting the free parts of the filaments.

According to one embodiment of the invention, the forming of themanipulation member includes: providing a tube; cutting off apredetermined number of the free parts of the filaments extended fromthe proximal end of loops and axially disposing the remaining filamentswithin a lumen of the tube along at least a portion of the tube'slength.

According to another embodiment of the invention, the forming of themanipulation member includes: providing a tube; cutting off all the freeparts of the filaments extended from the proximal end of loops at apredetermined distance from a proximal end of the loops; placing freeends of the filaments obtained after cutting into a lumen of the tube;and crimping together the pipe and said free ends of the filamentsplaced in the tube.

According to a further embodiment of the invention, the forming of themanipulation member includes: providing a rod element; providing aferrule; cutting off all the free parts of the filaments at apredetermined distance from a proximal end of the loops; connecting freeends of the filaments obtained after cutting to the rod element throughthe ferrule by placing and crimping the ferrule around the rod elementand around the ends of filaments. The ferrule includes a notchconfigured for facilitation of the connection of the free ends of thefilaments to the rod element by at least one connecting techniqueselected from soldering, welding and gluing.

When desired, the method of snare fabrication further comprises the stepof attaching at least one radiopaque marker to at least one filamentloop.

According to yet another embodiment of the invention, the methodcomprises providing a dilator sheath adapted to penetrate into the bodyfor reaching the object; providing a manipulator configured formanipulating the snare for extraction of the object from the body,arranging the manipulation member within the dilator sheath; andconnecting the manipulation member to the manipulator. For example, theconnecting of the manipulation member to the manipulator can be carriedout by placing and crimping a ferrule around the manipulation member andthe manipulator.

There has thus been outlined, rather broadly, the more importantfeatures of the invention in order that the detailed description thereofthat follows hereinafter may be better understood. Additional detailsand advantages of the invention will be set forth in the detaileddescription, and in part will be appreciated from the description, ormay be learned by practice of the invention.

Further objects, features and advantages of the invention will becomeapparent from consideration of the following description and theappended claims when taken in connection with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carriedout in practice, embodiments will now be described, by way ofnon-limiting example only, with reference to the accompanying drawings,in which:

FIGS. 1A and 1B illustrate a plan view and a top view, respectively, ofa distal portion of a retrieval snare in a deployed position, accordingto one embodiment of the present invention;

FIG. 1C illustrates a plan view of a distal portion of a retrieval snarein a deployed position, according to another embodiment of the presentinvention;

FIGS. 2A and 2B illustrate a plan and a top view, respectively, of thesnare shown in FIGS. 1A and 1B in a partially collapsed position whenthe snare is partially retracted in a dilator sheath;

FIGS. 3A and 3B illustrate a side view of the snare shown in FIGS. 2Aand 2B during a further retraction in the dilator sheath;

FIG. 4 illustrates a schematic view of connection of the loops of theretrieval snare shown in FIG. 1A to a manipulation member, according toone embodiment of the invention;

FIG. 5 illustrates a schematic view of connection of the loops of theretrieval snare shown in FIG. 1A to a manipulation member, according toanother embodiment of the invention;

FIG. 6 illustrates a side view of a further embodiment of a manipulationmember of the retrieval snare of the invention;

FIG. 7 illustrates a flowchart diagram that describes the method formanufacturing a retrieval snare, in accordance with one embodiment ofthis invention; and

FIGS. 8A and 8B illustrate a perspective and top view, respectively, ofan exemplary weaving jig utilized for preparation of a retrieval snareof the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Detailed embodiments of the present invention are disclosed herein. Itis understood however, that the disclosed embodiments are merelyexemplary of the invention and may be embodied in various andalternative forms. The figures are not necessarily to scale; somefigures may be exaggerated or minimized to show the details of aparticular component. Therefore, specific structural and functionaldetails disclosed herein are not to be interpreted as limiting, butmerely as a representative basis for the claims and for teaching oneskilled in the art to practice the present invention.

Embodiments of the present invention provide a snare that includes acentral structure with a plurality of loops at the distal end of thestructure. In order to strengthen the construction, the loops areconnected together at joinder length sections located between the distaland proximal ends of the loops to maintain the relative geometry of theloops in both an expanded and compressed condition.

FIGS. 1A and 1B illustrate plan and top views, respectively, of a distalportion of a retrieval snare 10 in a deployed position for entrappingand retaining a foreign object according to one embodiment of thepresent invention. In general, the structure of the retrieval snare 10has a petal shape and comprises a proximal portion 11 and a distalportion 12. The structure is formed by a plurality of filaments thatextend from an end 13 of the proximal portion 11 towards the distalportion 12 and then return to the end 13 to form a plurality of filamentloops 14. In the proximal portion 11, each side 14 a of each loop 14 isdirectly connected to a side 14 a of an adjacent loop 14 at continueslength sections (i.e., at more than one point) between the end 13 and adistal connection point 16. This feature provides sufficient structuralrigidity and dilatation ability to the snare. However, the loops 14 arenot interconnected in the distal portion 12. Specifically, the loops 14deploy radially outward and away from each other in the distal portion12 when the snare is deployed outside a dilator sheath 15.

The dilator sheath 15 is a thin-walled, cylindrical flexible tubeadapted to penetrate into the body for reaching the foreign object. Forexample, the dilator sheath 15 can be made of a plastic material, suchas polyvinyl chloride, NYLON, TEFLON, etc. The dilator sheath 15 canalso be made of metal material. For example, it can be made in the formof a coil, (e.g., stainless steel coil) or a metal tube.

When desired, the sheath 15 may be multi-layered with differentmaterials in order to provide a graduated bending and stiffnesscharacteristic over its length.

Attention is now drawn to the configuration of the filament loops 14themselves. According to one embodiment of the invention, the filamentloops 14 are generally flat and planar. According to another embodimentof the invention, each side 14 a of the filament loops is slightly bentor arcuate, as illustrated in FIG. 1A, into an arc (C-shapedconfiguration). Such a configuration can enhance the ability to slip theloops over the foreign object and grasp it. According to still anotherembodiment of the invention, each side 14 a of the filament loops isslightly undulated, as illustrated in FIG. 1C, into a somewhat S-shapedconfiguration. Such a configuration can facilitate retraction of thesnare into the sheath 15.

Preferably, an opening angle θ of the deployed snare is in the range ofabout 10 degrees to about 170 degrees. The effective value of theopening angle depends on the snare application, and is mainly determinedby the size of the foreign object. For the purpose of the presentinvention, when the loops are planar, the opening angle θ can be definedas an angle between planes of the diametrically opposite loops. When theloops are not planar, the opening angle θ can be defined as an anglebetween various parts of segments 141 connecting a distal end 142, amidpoint 144, and a proximal end 143 of the loops 14. It should be notedthat the proximal end 143 of the loops 14 coincides with the end 13 ofthe proximal portion 11. It should be understood that when the loops arenot planar the segments 141 are also bent. Therefore, the value of theangle θ varies along the loop length. In particular, for theconfiguration when the loops are bent (see FIG. 1A), the value of theangle θ is relatively large near the proximal end 143 and small near thedistal end 142. In turn, when the loops are undulated (see FIG. 1C), thevalue of the angle θ can be relatively small near the proximal end 143,comparatively larger near the midpoint 144 of the loop (i.e. where theloop changes slope), and comparatively smaller adjacent the distal end142.

It should be understood that although an exemplary snare having fourfilament loops 14 is illustrated in FIGS. 1A-1C and further drawings,the invention is not limited by such a structure. Generally, any desirednumber of the loops equal to or greater than two may be utilized.

According to one embodiment of the present invention, the connection ofthe sides 14 a of the loops 14 in the proximal portion 11 is achieved bytwisting each pair of the corresponding sides 14 a by one or more turnsand forming twisted parts 21.

The filaments are bound together at the end 13 of the proximal portion11. According to an embodiment of the invention, the filaments are boundtogether by a ferrule 17 crimped or swaged together with the filamentsat the end 13 of the proximal portion.

According to another embodiment of the invention, best shown in FIG. 1A,the filaments that extend from the end 13 outside the proximal portion11 toward a manipulation member 19, are twisted together. Thus, thesetwisted filaments can possess sufficient stiffness in order to form orbe a part of the manipulation member 19 of the snare 10. Themanipulation member 19 is arranged within the dilator sheath 15 andoperable for retracting the snare within the sheath 15 and protractingthe snare therefrom for its opening. The manipulation member 19 connectsthe snare 10 to a manipulator (not shown) that is operable formanipulating the snare for extraction of the foreign object from thebody. According to one embodiment of the invention, the manipulationmember 19 is formed from at least a part of the plurality of filamentsextending from the end 13 towards the manipulator.

In practice, an operator of the snare can manipulate the manipulationmember 19 by means of the manipulator, and thus the snare 10 can beeither retracted within the catheter 15 or protracted therefrom. Theoperator, by holding the manipulator, can also maneuver the catheter 15within the body organ (not shown), (e.g. to displace it by turning,pushing or pulling).

Referring to FIG. 4, a retrieval snare apparatus 40 is shown whichincludes at least one of the snares described above and further includesa manipulation member 41 having a tube 42 containing all or at least apart of the plurality of filaments extending from the end 13 towards amanipulator 44. When desired, the filaments can be twisted together toprovide additional rigidity to the manipulation member. These filamentsare axially disposed within a lumen of the tube 42 along at least aportion of the tube's length. The tube 42 and the filaments can be boundtogether. For example, the tube and the filaments can be crimped,swaged, glued, soldered or welded together. When desired to increase thesurface area binding the filaments to the tube, the tube 42 can have oneor more notches (not shown) through which a glue or soldering materialcan be delivered. In some embodiments, the tube 42 may be disposedwithin the dilator sheath 15 described above (not shown), therebyforming a snare control assembly.

In another embodiment, the tube 42 may be arranged between a firstferrule 43 and the manipulator 44, as shown in FIG. 4. Alternatively,the tube 42 can bind together the filaments at the end 13 of theproximal portion 11, essentially functioning as the first ferrule 43,and thereby allowing the ferrule 43 to be omitted. The tube 42 can, forexample, be made of a metallic material selected from a NiTi basedalloy, or stainless steel. Likewise, the tube 42 can be made of apolymer material. According to one example, the manipulation member 41can be connected to the manipulator 44, for example, through a secondferrule 45 placed and crimped around the tube 42 and the manipulator 44.According to another example, the manipulation member 41 can be directlyconnected to the manipulator 44, omitting the ferrule 45. Thus, if themanipulator 44 has a cannular end, it can be put on the tube 42 andconnected by gluing, soldering and/or welding process. To increase thebinding surface, the manipulator 44 can be provided with one or morenotches (not shown) through which a glue or soldering material can bedelivered.

Referring to FIG. 5, a schematic view of connection of the retrievalsnare in FIG. 1A to a tube 51 in order to form a manipulation member 50of the retrieval snare apparatus is shown, according to anotherembodiment of the present invention. According to this embodiment, theplurality of filaments extended from the end 13 are cut off at apredetermined distance from the end, thereby forming free ends 52 of theplurality of filaments. These free ends 52 are placed in a lumen of thetube 51 and are crimped or welded together at position 54, thereby toform the manipulation member. The tube 51 of the manipulation member canbe connected to a manipulator 53, for example, through a fourth ferrule55 placed and crimped around the tube and the manipulator 53. Accordingto another example, the manipulation member 50 can be directly connectedto the manipulator 53 omitting the ferrule 55. Thus, the manipulator 53can be put on the tube 42 and connected by gluing, soldering and/orwelding process. As discussed above, the manipulator 53 can be providedwith one or more notches (not shown) through which a glue or solderingmaterial can be delivered to increase the binding surface area.

FIG. 6 shows yet another embodiment of a manipulation member of theretrieval snare of the present invention. According to this embodiment,similar to the previous embodiment, the plurality of filaments extendingfrom the end 13 are cut off at a predetermined distance from the end toform free ends 61 of the plurality of filaments. The free ends 61 areconnected to a rod element 62. In this case, the rod element 62 isanalogous to the manipulation member (41 in FIG. 4).

For example, the connection of the rod element 62 to the free ends 61 ofthe filaments can be implemented through welding or soldering. Likewise,the connection of the rod element 62 to the free ends 61 of thefilaments can be implemented through a fifth ferrule 63 placed andcrimped around the rod element 62 and around the free ends. Whendesired, the fifth ferrule 63 can include a notch 64 configured tofacilitate connecting the rod element 62 to the ferrule 63 by at leastone connecting technique selected from soldering, welding and gluing.

The rod element 62 can be connected to a manipulator 65, for example,through a sixth ferrule 66 placed and crimped around the rod element 62and the manipulator 65. As described above, the rod element 62 can alsobe directly connected to the manipulator 65, for example, by usinggluing, soldering or welding process.

The rod element 62 of the manipulation member can, for example, be madeof a metallic material, such as a NiTi based alloy or stainless steel.Likewise, the rod element 62 can be made of a polymer material.

According to one embodiment of the invention, each filament is asingle-core wire. According to another embodiment of the invention, eachfilament is a multi-wire strand.

The filaments utilized for the fabrication of the retrieval snare 10 aremade of a suitable material that is suitably biocompatible and hasthermo-mechanical shape memory and/or superelastic properties. Accordingto one embodiment of the invention, the filaments are made of a metallicmaterial. For example, the metallic material can be selected from agroup including a NiTi based alloy (e.g., Nitinol), stainless steel andother materials possessing good shape memory, elastic or superelasticcharacteristics. According to another embodiment of the invention, thefilaments are made of non-metallic material, for example Capron, Nylon,etc.

According to a still further embodiment of the invention, the filamentsof the basket are covered by an insulating layer. The insulating layercan, for example, be made of Teflon. The advantage of Teflon is itsthermal resistance and low coefficient of mechanical friction, whichleads to an additional reduction of traumatism.

A preferable, but not mandatory feature has, the filaments beingradiopaque, so as to permit them to be visualized by a fluoroscope withrespect to the object to be retracted. Thus, according to one example,radiopacity may be provided by the metallic material from which thefilaments are made and may include a material which providesradiopacity, for example a noble metal, such as gold, tantalum,platinum, etc. Likewise, the metallic material can be alloyed with oneor more of the following metals: Pd, W, Nb, Co, Ta, and Cu.

According to another example, the filaments are made of a core tube(cannular strand) containing an axially disposed radiopaque wire, forexample, a radiopaque core clad with a different outer material.Examples of radiopaque materials include Pt, Au, Pd, W, Nb, Co, Ag, Ta,and Cu without limitation. Examples of cladding materials includestainless steel, Nitinol, and plastics such as Capron and Nylon withoutlimitation.

According to yet another example, the filaments can have radiopaqueparts of a predetermined length. These radiopaque parts can form thedistal portion (12 in FIG. 1) of the snare or at least a part of thedistal portion.

Radiopacity can also be improved through coating processes such assputtering or plating a radiopaque material onto the filaments, or thesnare fabricated from these filaments, thereby to provide a radiopaquecoating layer on the filaments.

Likewise, radiopacity can yet be improved by using radiopaque markerswhich can be attached to or placed around the filaments forming thesnare. In this manner, materials which have higher radiopacity than thesnare structure itself, such as gold, tantalum or platinum, can beutilized as markers and be strategically placed along the body of thesnare to increase the visualization of the snare. For example, theretrieval snare 10 can comprise one or more radiopaque markers (18 inFIG. 1A) attached to or placed around the filaments forming one or moreloops (14 in FIG. 1A) in the distal portion (12 in FIG. 1A). Forexample, the radiopaque marker can be a ferrule put on the filament.

According to another embodiment of the invention, the filaments can bemulti-wire strands. In such a case, in order to improve radiopacity, themulti-wire strands can include a central core wire and at least oneanother wire twisted about said central core wire which is made of amaterial having a level of radiopacity greater than the level ofradiopacity of said central core wire. Examples of such a materialinclude, but are not limited to, Pt, Au, Pd, Ag, Ta, etc.

Referring now to FIGS. 2A and 2B, a plan view and a top view are shown,respectively, of the snare shown in FIGS. 1A and 1B in a partiallycollapsed position when the snare is partially retracted in a dilatorsheath. In this case, the opening angle is decreased.

According to the invention, when the sides 14 a of the adjacent loops 14are connected by twisting, the distal connection points 16 of theadjacent loops 14 can slide along the filaments' length when the snare10 is retracted in the dilator sheath 15. Specifically, when thetwisting is formed by two or more turns, the distal connection points 16can move from the twisted parts 21 of the loops 14 toward the distalportion 12 of the snare, thereby forming an intermediate portion 22between the proximal portion 11 and the distal portion 12 of the snare10. The intermediate portion 22 includes convex cells 23 formed betweenthe distal points 16 and the remaining twisted parts 21 by thecorresponding pair 24 of the filaments separated from each other. Itshould be understood that when the twisting is formed by only one turn(not shown), the convex cells are formed between the end 13 of theproximal portion 11 and the distal connection points 16.

FIGS. 3A and 3B show the snare shown in FIGS. 2A and 2B during a furtherretraction in the dilator sheath 15. In this case, the proximal portion(11 in FIGS. 2A and 2B) is located in the sheath 15, the distalconnection points 16 move further towards a distal end 31 of the snareof the present invention, and the opening angle θ further decreases.

Having explained the structure of the retrieval snare of the presentinvention, a process of manufacturing the snare will be describedhereinbelow.

Referring to FIG. 7, the process begins from a step of providing (block71) of a predetermined number of filaments having predeterminedproperties, predetermined diameter and length.

According to one non-limiting example of the process, the manufacturingof the retrieval snare is carried out from one length of filament.

According to another non-limiting example of the process themanufacturing of the retrieval snare is carried out from severalfilaments. In this case, the number of the filaments is equal to thenumber of the filament loops of the snare.

The filaments selected for the construction of the snare can besingle-core wires, or when desired, can be multi-wire strands.

When desired to manufacture a snare with radiopaque characteristics, thefilaments can have radiopaque parts of a predetermined length. Accordingto one embodiment of the invention, in order to prepare the filamentswith radiopaque parts, the fabrication method can include providingradiopaque coils having the predetermined length, which can be put on acore wire in the desired locations along the wire length. In order toavoid sliding the coils along the core wire, the coils can be welded,soldered and/or glued to the wire. Other method of binding the coils tothe core wire can also be utilized. For example, each coil can be fixedon the core wire by means of two ferrules put on and crimped togetherwith the core wire at the two ends of the coil.

According to one embodiment of the invention, in order to prepare thefilaments with radiopaque parts, the fabrication method can includeproviding radiopaque ferrules and placing the ferrules on a core wireand crimping them in the desired locations along the wire length.

After providing the filaments, the process for the fabrication of theretrieval basket includes weaving the retrieval snare from one length offilament or from several filaments.

According to the invention, at least a part of the preparation of thesnare is carried out on a weaving jig (block 72). FIGS. 8A and 8B show aperspective and top view, respectively, of an exemplary weaving jig 80suitable for preparation of the retrieval snare of the presentinvention. The jig 80 has a structure including grooves arranged inaccordance with the desired pattern of the snare of the invention andhas a shape that imitates the desired shape of the snare. Specifically,the weaving jig 80 has a working surface 81, where the working surfacehas a predetermined convex shape defining an opening angle of the snare,and a predetermined pattern formed by radial channels 82 and concentricgrooves 85 configured on the surface. The working surface 81 has acentral portion 83 and a peripheral portion 84. The radial channels 82are formed in the form of a plurality of notches extending from a center86 of the surface towards the peripheral portion 84. The notches are notinterconnected at the peripheral portion 84 of the working surface 81,but each notch merges with an adjacent notch at a shared common part 87of the radial channels 82 in the central portion 83.

Referring to FIG. 7 and FIGS. 8A-8B together, the process for thefabrication of the retrieval snare of the present invention furtherincludes weaving the retrieval snare on the jig 80. Specifically, thefilaments are placed (block 73) into the radial channels 82 to form aplurality of filament loops in accordance with a desired pattern of thesnare structure. Free parts of the filaments are arranged in the center86 of the working surface 81 of the jig 80.

In order to avoid the filaments slipping from the jig 80 and unweavingthe snare, the filament loops are fastened (block 74) to the jig at theperipheral portion 84 of the working surface of the jig. For thispurpose the filaments forming the loops can be tied up on the jig 80,for example, by one or more strings (not shown in FIG. 8) wound aroundthe jig in the concentric grooves 85. The strings can, for example, bemade of soft wire having strength sufficient to maintain the fixture ofthe loops on the jig. Examples of the soft wire include, but are notlimited to a copper wire or annealed manganin wire.

Thereafter, the process includes the step of connecting (block 75) eachside of each filament loop disposed in the common part 87 of the radialchannels 82 to a side of an adjacent filament loop at more than onepoint. According to an embodiment of the invention, the connection ofthe sides in the common part of the radial channels 82 is achieved bytwisting each pair of the filaments forming the corresponding sidesalong the peripheral portion 84. In this case, the number of theconnection points determines structural rigidity of the snare. Thisnumber is defined by the number of turns in the twisted portions of theloops.

Further, free parts of the filaments (not shown) arranged in the center86 of the working surface and extended therefrom are fastened together(block 76). This fastening can, for example, be carried out by atemporal or permanent ferrule (not shown). This ferrule can, forexample, be in the form of a pipe made of metal, for example, Ni,stainless steel, etc. The ferrule can be squeezed (crimped) for fixationof the filaments therein. It should be appreciated that this is only anon-limiting example of the filaments' fixation. Other techniques canalso be used, for example, soldering, welding or gluing.

The process of snare fabrication further includes annealing (block 77)of the retrieval snare for memorizing and storing the snare shape andthereby imparting structural rigidity and dilatation ability to thesnare. The parameters of the annealing depend on the materials of thefilaments and the method of heating. For example, when such material isNitinol, the annealing can be carried out at the temperature of about400° C.-600° C. for about ten min. Such heat treatment relieves internalstresses in the material and provide the memorization of the basketshape. It should be understood that the time for the annealing may beshorter or longer than 10 minutes, depending on the heating technique,jig mass, etc. For example, when the treatment is carried out in afurnace, the treatment time should include the time of heating the jig.

It should be appreciated that the invention is not limited to thespecific implementation of the annealing step. According to oneembodiment, the heating is carried out by placing the snare mounted onthe weaving jig in a furnace configured for this purpose.

According to another embodiment, the heating is carried out by passingan electric current through the filaments that in this case should bemade from at least partially electrically conducting material. Forexample, when the material is Nitinol a current of about one to threeamps applied over about two seconds to tens of seconds can be used.

After the annealing, the snare mounted on the jig is cooled (block 78).Then, the parts of the filaments tied at the peripheral portion 84 ofthe working surface of the jig and, if desired in the center 86, andthen are unfastened (block 79); and the jig 80 is removed (block 710).

Thereafter, if the filaments at the end of the proximal portion are notbound, (as might happen when the parts of the filaments tied in thecenter 86 of the jig are unfastened for removal of the jig), then thefree parts of the filaments at the end of the proximal portion are boundpermanently together (block 711). The binding of the free parts of thefilaments together can, for example, be carried out by a permanentferrule.

According to yet another embodiment, when the retrieval snare is formedfrom a single length of filament, in order to place the filament in theradial channels 82 one end of the single length of filament is fixed,while the other end is put on the working surface 81 of the jig 80 andmoved along the notches of the radial channels 82. The weaving of thesnare continues by moving the free end away from the jig and returningit thereto as long as desired to form filament loops. After forming theloops the method repeats all the steps described above.

Furthermore, when desired, the process for fabrication of the retrievalbasket can include a step of forming a manipulation member.

According to one embodiment of the invention, for the forming of amanipulation member, a certain number of filaments extending from theend of the snare proximal portion can be cut off, and the remaining wirefilaments can be twisted together. In a preferred, but not requiredembodiment, the twisted wire filaments are then squeezed and heated formemorizing and storing the twisted form. As described above, the heatingcan, for example, be performed by applying an electric current acrossthe rod. For example, when the material is Nitinol a current of abouttwo to three amps applied over about two to five seconds can be used. Itshould be understood that the time and current values also depend on thefilament diameter and the materials and generally may be shorter thantwo seconds or longer than five seconds.

According to one embodiment of the invention, the forming of themanipulation member, as shown in FIG. 4, includes the steps of providingthe tube 42, cutting off one or more free parts of the filamentsextended from the end 13, and axially disposing the remaining filamentswithin a lumen of the tube 42 along at least a portion of the tube'slength. For additional stiffness, the remaining filaments can be twistedtogether before their disposing within the lumen of the tube 42. Forfacilitation of the contact between the inner surface of the tube andthe filaments, the tube and the filaments can be crimped together. Whendesired, other binding techniques can be used, such as gluing, solderingand/or welding these filaments to the tube.

According to another embodiment of the invention, the forming of themanipulation member, as shown in FIG. 5, includes the steps of providinga tube 51, cutting off the free parts 52 of the filaments at apredetermined distance from the proximal end 13 of the loops, placingfree ends 54 of the filaments obtained after the cutting into a lumen ofthe tube 51, and crimping together the pipe 51 and the free ends 54 ofthe filaments placed in the pipe 51.

According to a further embodiment of the invention, the forming of themanipulation member, as shown in FIG. 6, includes the steps of providingthe rod element 61, providing the ferrule 62, cutting off all the freeparts of the filaments at a predetermined distance from the proximal end13 of the loops, and connecting the free ends 67 of the filamentsobtained after cutting to the rod element 61 through the ferrule 62 thatis placed around the rod element 61 and around the ends 67 of thefilaments. When desired, the ferrule 62 includes a notch 64 configuredfor facilitation of the connection of the free ends 67 of the filamentsto the rod element 61 by using at least one connecting techniqueselected from soldering, welding and gluing.

The method of fabrication of the retrieval snare can further includeproviding a dilator sheath (15 in FIG. 1A) adapted to penetrate into thebody for reaching the object.

The method of fabrication of the retrieval snare can further include thesteps of providing the manipulator (44 in FIG. 4; 53 in FIG. 5; 65 inFIG. 6) configured for manipulating the snare for extracting the objectfrom the body, arranging the manipulation member (41 in FIG. 4; 50 inFIG. 5) within the dilator sheath, and connecting the manipulationmember to the manipulator. The connecting of the manipulation member tothe manipulator can, for example, be carried out by using a ferrule thatis placed and crimped around the manipulation member and themanipulator.

From the foregoing description it should be appreciated that retrievalsnares constructed in accordance with the present invention can comprisea variety of user desired shapes, number of loops, shape of the loops,types of connection of the loops in the proximal portion and types ofconnection of the loops to a manipulation member.

As such, those skilled in the art to which the present inventionpertains, can appreciate that while the present invention has beendescribed in terms of preferred embodiments, the concept upon which thisdisclosure is based may readily be utilized as a basis for the designingof other structures and processes for carrying out the several purposesof the present invention.

It should be understood that the snare of the present invention is notlimited to a medical treatment of a human body. It can be successfullyemployed for medical treatments of animals as well. Furthermore, thedevice of the invention is suitable for retrieval of foreign objectsfrom various cavities in the body systems, for example, from bloodvessels, urination tract, etc.

Moreover, the present invention is not limited to fabrication of medicaldevices, thus the snare device of the invention can be used to extractany type of article from a wide range of inaccessible locations such asinside a pipe or tube (for example, the waste outlet of a domestic sink)or inside a chamber within a large piece of machinery which would bedifficult to dismantle.

Also, it is to be understood that the phraseology and terminologyemployed herein are for the purpose of description and should not beregarded as limiting.

In the method claims that follow, alphabetic characters used todesignate claim steps are provided for convenience only and do not implyany particular order of performing the steps.

It is important, therefore, that the scope of the invention is notconstrued as being limited by the illustrative embodiments set forthherein. Other variations are possible within the scope of the presentinvention as defined in the appended claims and their equivalents.

The invention claimed is:
 1. A retrieval snare for entrapping andretaining a foreign object located in a body for its extractiontherefrom, the snare comprising: a structure having a proximal portionand a distal portion and including a plurality of filaments extendingfrom a proximal end of the proximal portion to a distal end of thedistal portion and returning to the proximal end to form a plurality ofloops, each of the loops being formed by a single filament and beingfree and unattached to any adjacent loops at the distal portionincluding the distal end in a fully expanded condition, the proximalportion of each loop consisting of two proximal sides that areunattached to each other in the fully expanded condition, each of theproximal sides directly connected along the proximal portion to aproximal side of an adjacent loop at more than one connection point forstructural rigidity and dilatation ability to the snare, the pluralityof loops being configured to deploy radially outward in both theproximal portion and the distal portion and away from each other in thedistal portion including the distal end during a movement from acompressed condition to the fully expanded condition.
 2. The retrievalsnare of claim 1 wherein the connected proximal sides of the adjacentloops along the proximal portion form a pair of the filaments connectedby twisting each pair of the filaments, thereby creating twisted partsof the loops between the proximal end and distal connection points. 3.The retrieval snare of claim 1 wherein the filaments are bound togetherat the proximal end of the proximal portion to form a manipulationmember.
 4. The retrieval snare of claim 1 wherein the loops are selectedfrom: planar, bent into C-shaped configuration, and bent into S-shapedconfiguration.
 5. The basket of claim 1 wherein the filaments are madeof metallic material.
 6. The retrieval snare of claim 5 wherein themetallic material has at least one of thermo-mechanical shape memory andsuperelastic characteristics.
 7. The retrieval snare of claim 1 whereinthe filaments are made of non-metallic material.
 8. The retrieval snareof claim 5 wherein the metallic material includes a radiopaque material.9. The retrieval snare of claim 1 wherein the filaments are made of acore tube containing an axially disposed radiopaque wire.
 10. Theretrieval snare of claim 1 wherein the filaments are covered by acoating layer made of a radiopaque material.
 11. The retrieval snare ofclaim 1 wherein parts of the filaments are covered by radiopaque coils.12. The retrieval snare of claim 1 wherein the filaments are multiwirestrands.
 13. A retrieval snare for entrapping and retaining a foreignobject located in a body for its extraction therefrom, the snarecomprising: a structure having a proximal portion and a distal portionand including a plurality of filaments, the plurality of filamentsextending from a proximal end of the proximal portion to a distal end ofthe distal portion and returning to the proximal end to form a pluralityof loops, each of the loops being formed by a single filament and beingfree and unattached to any adjacent loops at the distal portionincluding the distal end in a fully expanded condition, the proximalportion of each loop consisting of two proximal sides that areunattached to each other in the fully expanded condition, each of theproximal sides directly connected along the proximal portion to aproximal side of an adjacent loop at more than one connection point forstructural rigidity and dilatation ability to the snare, the pluralityof loops being configured to deploy radially outward in both theproximal portion and the distal portion and away from each other in thedistal portion including the distal end during a movement from acompressed condition to the fully expanded condition; wherein theconnected proximal sides of the adjacent loops along the proximalportion form a pair of the filaments connected by twisting each pair ofthe filaments, thereby creating twisted parts of the loops between theproximal end and distal connection points, and wherein the distalconnection points of the adjacent loops are movable from the twistedparts of the loops toward the distal portion of the snare when the snareis retracted in a sheath thereby forming an intermediate portion betweenthe proximal portion and the distal portion of the snare, theintermediate portion including convex cells bounded by an overlap ofadjacent loops between the distal connection points and the twistedparts of the loops where the corresponding pair of the filamentsseparate from each other.
 14. A retrieval snare apparatus for entrappingand retaining a foreign object located in a body for its extractiontherefrom, the snare apparatus comprising: a retrieval snare forentrapping and retaining a foreign object located in a body for itsextraction therefrom, the snare comprising a structure having a proximalportion and a distal portion and including a plurality of filamentsextending from a proximal end of the proximal portion to a distal end ofthe distal portion and returning to the proximal end to form a pluralityof loops, each of the loops being formed by a single filament and beingfree and unattached to any adjacent loops at the distal portionincluding the distal end in a fully expanded condition, the proximalportion of each loop consisting of two proximal sides that areunattached to each other in the fully expanded condition, each of theproximal sides directly connected along the proximal portion to aproximal side of an adjacent loop at more than one connection point forstructural rigidity and dilatation ability to the snare, wherein theloops are not interconnected in the distal portion including the distalend and are configured to deploy radially outward in both the proximalportion and the distal portion and away from each other in the distalportion including the distal end during a movement from a compressedcondition to the fully expanded condition; and a snare control assemblycoupled to the snare structure, said snare control assembly comprising asheath adapted to penetrate into the body for reaching the object, amanipulator for manipulating the snare for extraction of the object fromthe body, and a manipulation member arranged within the sheath forconnecting the snare to the manipulator, the snare control assemblybeing configured for retracting the snare within the sheath andprotracting the snare therefrom for its opening.
 15. The retrieval snareapparatus of claim 14 wherein the manipulation member includes at leasta part of the plurality of filaments extending from the proximal endtowards the manipulator.
 16. The retrieval snare apparatus of claim 14wherein the manipulation member includes a tube containing the part ofthe plurality of filaments axially disposed within a lumen of the tubealong at least a portion of the length of the tube.
 17. The retrievalsnare apparatus of claim 14 wherein the part of the plurality offilaments extended from the proximal end of the proximal portion towardsthe manipulator are cut off at a predetermined distance from theproximal end, forming free ends of the plurality of filaments.
 18. Theretrieval snare apparatus of claim 17 wherein the manipulation member ismade of a material including at least one of NiTi based alloy, stainlesssteel, and polymer.
 19. A retrieval snare for entrapping and retaining aforeign object located in a body for its extraction therefrom, the snarecomprising: a structure having a proximal portion and a distal portionand including a plurality of filaments extending from a proximal end ofthe proximal portion to a distal end of the distal portion and returningto the proximal end to form a plurality of loops, each of the loopsbeing formed by a single filament and being free and unattached to anyadjacent loops at the distal portion including the distal end in a fullyexpanded condition, the proximal portion of each loop consisting of twoproximal sides that are unattached to each other in the fully expandedcondition, each one of the proximal sides directly connected along theproximal portion to one adjacent proximal side of an adjacent loop atmore than one connection point, including one most distal connectionpoint and one next-to-distal connection point, the most distalconnection point being located at a shorter distance from the proximalend and closer to the next-to-distal connection point in the fullyexpanded condition than in a collapsed condition.